The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.

Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Premenopausal women, at least 18 years of age

Diagnosis of uterine fibroid(s), confirmed by ultrasound

History of menstrual cycles between 17 and 42 days

Otherwise in good health

Scheduled for a hysterectomy at the end of the treatment period

Negative pregnancy test

Agrees to double barrier method of contraception

Pap test with no evidence of malignancy or pre-malignant changes

Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

Less than 3 months after having a baby or breast-feeding

Any abnormal lab or procedure result the study-doctor considers important

Severe reaction(s) to or are currently using any hormone therapy

History of cancer or alcohol or drug abuse

Diagnosis of Polycystic Ovary Syndrome

History of prolactinoma

Current use of Intrauterine Device

Significant gynecological disorder

Uterine size > 32 weeks gestation

Current diagnosis of endometriosis

Uterine artery embolization within 6 months

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150644